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Training Obstetrische Spoed Teams Interventie- studie.


- candidate number6002
- NTR NumberNTR1859
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jun-2009
- Secondary IDs170992303 ZonMW
- Public TitleTraining Obstetrische Spoed Teams Interventie- studie.
- Scientific TitleReducing errors in health care: cost-effectiveness of multidisciplinary team training in obstetric emergencies.
- ACRONYMTOSTI trial
- hypothesisThere are many avoidable deaths in hospitals because the care team is not well attuned. Training in emergency situations is generally followed on an individual basis. In practice, however, hospital patients are treated by a team composed of various disciplines. To prevent communication errors, it is important to focus the training on the team as a whole, rather than on the individual. Team training appears to be important in contributing toward preventing these errors. Obstetrics lends itself to multidisciplinary team training. It is a field in which nurses, midwives, obstetricians and paediatricians work together and where decisions must be made and actions must be carried out under extreme time pressure. It is attractive to belief that multidisciplinary team training will reduce the number of errors in obstetrics. The other side of the medal is that many hospitals are buying expensive patient simulators without proper evaluation of the training method. In the Netherlands many hospitals have 1,000 or less annual deliveries. In our small country it might therefore be more cost-effective to train obstetric teams in medical simulation centres with well trained personnel, high fidelity patient simulators, and well defined training programmes. The aim of the present study is to evaluate the cost-effectiveness of multidisciplinary team training in a medical simulation centre in the Netherlands to reduce the number of medical errors in obstetric emergency situations.
- Healt Condition(s) or Problem(s) studiedObstetric emergencies
- Inclusion criteriaTeaching and non-teaching hospitals in the Netherlands which do not have frequently multidisciplinary team training.
- Exclusion criteriaHospitals which already have frequently multidisciplinary team training for its care workers.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2009
- planned closingdate31-mei-2012
- Target number of participants20
- InterventionsThe intervention group will have multidisciplinary team training in a medical simulation centre. These team trainings are given by specially trained instructors and facilitators (gynaecologists, anaesthesiologists, emergency care doctors, midwives, educationalists, medical engineers and psychologists). All instructors and facilitators are trained in crew resource management. The control group will not have multidisciplinary team training in a medical simulation centre.
- Primary outcomePrimary outcome is the number of obstetric complications throughout the first year after the intervention. Obstetric complications will be defined as the number of neonates with perinatal asphyxia (Apgar 5-minutes <6 and/or arterial umbilical pH < 7.05, hypoxic ischemic encephalopathy (H.I.E.), number of newborns with damage caused by shoulder dystocia (lesion of brachial plexus, clavicle fracture), number of women with eclampsia, number of women with severe post partum haemorrhage (blood transfusion >4 packed cells), hysterectomy, embolisation), number of women with amniotic fluid embolism. These complications will be obtained from the regular obstetric recordings (with exception of damage due to shoulder dystocia and severe postpartum haemorrhage, these data will be registered separately).
- Secondary outcomeBefore the start of the project indicators will be developed to evaluate patient safety, teamwork and human factors. These indicators will be registered in a subgroup of the participating hospitals.
- TimepointsData (the number of obstetric complications) will be collected one year after the intervention.
- Trial web sitehttp://www.studies-obsgyn.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Ven, van de
- CONTACT for SCIENTIFIC QUERIES J. Ven, van de
- Sponsor/Initiator ZonMw: The Netherlands Organization for Health Research and Development, Máxima Medical Center, Maastricht University Medical Center (MUMC+), VGZ, health insurance company , CZ, health insurance company, Eindhoven University of Technology, Koninklijke Visio, Stimulus foundation by MMC
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBackground:
There are many avoidable deaths in hospitals because the care team is not well attuned. Training in emergency situations is generally followed on an individual basis. In practice, however, hospital patients are treated by a team composed of various disciplines. To prevent communication errors, it is important to focus the training on the team as a whole, rather than on the individual. Teamtraining appears to be important in contributing toward preventing these errors. Obstetrics lends itself to multidisciplinary team training. It is a field in which nurses, midwives, obstetricians and paediatricians work together and where decisions must be made and actions must be carried out under extreme time pressure. It is attractive to belief that multidisciplinary team training will reduce the number of errors in obstetrics. The other side of the medal is that many hospitals are buying expensive patient simulators without proper evaluation of the training method. In the Netherlands many hospitals have 1,000 or less annual deliveries. In our small country it might therefore be more cost-effective to train obstetric teams in medical simulation centres with well trained personnel, high fidelity patient simulators, and well defined training programmes.
Methods/design:
The aim of the present study is to evaluate the cost-effectiveness of multidisciplinary team training in a medical simulation centre in the Netherlands to reduce the number of medical errors in obstetric emergency situations. We plan a multicentre randomised study with the centre as unit of analysis. Obstetric departments will be randomly assigned to receive multidisciplinary team training in a medical simulation centre or to a control arm. To show a reduction in perinatal asphyxia of 40% (from 1% to 0.6%) two groups of more than 8,000 patients are necessary. Primary outcome is the number of obstetric complications throughout the first year period after the intervention. If multidisciplinary team training appears to be effective a cost-effective analysis will be performed.
Discussion:
If multidisciplinary team training appears to be effective, this training should be implemented in extra training for gynaecologists.

The Netherlands.
- Main changes (audit trail)07-Jan-2013: Many Dutch hospitals do not take umbilical pH levels. The definition of perinatal asphyxia will therefore be: Apgar score <7 after 5 minutes. Arterial umbilical pH <7.05 will become a secondary outcome. - NM
24-apr-2014: TOSTI-study part two
As a continuation of the TOSTI trial the control group will have multidisciplinary team training in a medical simulation centre based on the principles of deliberate practice (quasi-experimental study without control group). Data (number of obstetric complications) will be collected one year before and one year after the intervention. - AB
- RECORD24-jun-2009 - 24-apr-2014


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